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Summary of Contents for Micro Direct MicroRPM
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Page 1: Operating Manual
Respiratory Pressure Meter Operating Manual Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-800-588-3381 www.mdspiro.com 064-45 US Issue 1.4 September 2016... -
Page 2: Table Of Contents
Table of Contents Introduction ................. 1 Package Contents .............. 2 PUMA PC Software ............2 Contraindications ..............4 Warnings and Cautions ............4 Indications for Use .............. 5 Operation – mouth pressures (PImax/MIP + PEmax/MEP) . 6 PImax (MIP) Test ..............7 PEmax (MEP) Test ............. -
Page 3: Introduction
Introduction The respiratory pressure meter is a hand held instrument designed for rapid assessment of inspiratory and expiratory muscle strength. The unit can measure the maximum inspiratory and expiratory mouth pressures, MIP and MEP, and the Sniff Nasal Inspiratory Pressure, SNIP. The result of each measurement is presented in units of cmH O gauge pressure on the liquid crystal display screen. -
Page 4: Package Contents
Package Contents The respiratory pressure meter is supplied with the following items: - 1. Microcomputer unit 2. Rubber mouthpiece (Cat. No. MTH6400) 3. Alkaline PP3 battery 4. Expiration pressure valve assembly (Cat. No. ASS1221) 5. Inspiration pressure valve assembly (Cat. No. ASS1222) 6. -
Page 5: Puma Pc Software
PUMA PC Software The functionality of the portable MicroRPM is greatly increased when connected to the PUMA PC Software, via an RS232 cable to the Serial Port on the side of the unit. PUMA PC Software is available as a free download from http://www.carefusion.co.uk/our-products/respiratory-... -
Page 6: Contraindications
Note: The Respiratory Pressure Meter should only be connected to a computer that is manufactured in accordance with EN 60601-1. Note: Keep the PC out of reach of the patient at all times. Contraindications Pathological conditions resulting in relatively large pressure swings in the abdomen or thorax. -
Page 7: Indications For Use
IEC/EN 60601-1 / ANSI/AAMI ES60601-1:2005. Indications for Use The MicroRPM (Respiratory Pressure Meter) is a hand held diagnostic instrument designed for rapid assessment of inspiratory and expiratory muscle strength. The unit can measure the maximum inspiratory and expiratory mouth... -
Page 8: Operation - Mouth Pressures (Pimax/Mip + Pemax/Mep)
Fit the required pressure valve assembly (‘Inspiratory’ for PImax (MIP), ‘Expiratory’ for PEmax (MEP)) into the MicroRPM; insert a new bacterial filter into the pressure valve assembly and then the rubber flanged mouthpiece onto the bacterial filter as shown below. -
Page 9: Pimax (Mip) Test
MIP/MEP position, while applying no pressure to the mouthpiece. Rotating segments will be displayed while the unit performs an auto-zero function. When the MicroRPM is ready a ‘beep’ will be heard and ‘0’ will be displayed. To perform the test, instruct the subject to insert the mouthpiece into the mouth, ensuring the flange is positioned over the gums and inside the lips, while the ‘bite blocks’... -
Page 10: Operation - Snip (Sniff Nasal Inspiratory Pressure)
Ideally, the subject should repeat this test three times to establish a best value. To repeat either the PImax or PEmax tests, the MicroRPM must first be returned to the ‘Off’ position. Operation – SNIP (Sniff Nasal Inspiratory Pressure) Insert the battery into the rear of the MicroRPM. -
Page 11: Snip Test
Rotating segments will be displayed while the unit performs an auto-zero function. When the MicroRPM is ready a ‘beep’ will be heard and ‘0’ displayed. To perform the test, instruct the subject to insert the chosen nasal probe firmly into a nostril, while ensuring the other nostril remains open throughout the test. -
Page 12: Battery Low Voltage Indication
Battery Low Voltage Indication The battery level is checked when the unit is switched on. When the battery is nearly exhausted ‘bAt’ is displayed before the auto-zero procedure begins. The unit may be used when this occurs provided the test is performed immediately. -
Page 13: Cleaning Instructions
CAUTION: Do not open the battery cover when the device is turned on. CAUTION: The operator should not touch the contacts of the battery and the patient at the same time. Please Note: Dispose of the waste battery in accordance with your local waste battery regulations. -
Page 14: Cleaning Accessories
Cleaning accessories The MicroRPM unit is protected from contamination by the Bacterial Filter (36-FIL6050) during mouth pressures measurements. The Rubber Flanged Mouthpiece (MTH6400), the Expiratory and Inspiratory Pressure Valve Assembly (ASS1221 and ASS1222) and the Nasal Probes (NPROBE01, NPROBE02, NPROBE03, NPROBE04), however, may be immersed in a cold sterilizing solution. - Page 15 Turn the respiratory pressure meter on to the SNIP position. Very slowly fill the syringe until a negative pressure of between 200 and 300 cmH O is obtained on the manometer. The reading on the respiratory pressure meter should be within 3% of the manometer reading.
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Page 16: Servicing
If your unit requires service or repair, please see page 24 for contact details. A full service manual including circuit diagrams and parts list is available on request. Product Lifetime The MicroRPM is designed for a product lifetime of five years. -
Page 17: Trouble Shooting Information
Trouble Shooting Information Should you encounter problems operating your MicroRPM unit, please consult the table below: Problem Possible Cause Solution Unit will not turn Battery is Replace the spent/discharged battery Slide switch Return unit for connection servicing Display shows Internal tubing to... - Page 18 (including other medical devices). The purpose of this testing is to ensure that the MicroRPM is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the MicroRPM.
- Page 19 MicroRPM in relation to EMC performance. The MicroRPM should be used only with the accessories (RS232 cables) supplied (which are referenced in the accessories section of this manual). None of the MicroRPM cables should be extended in length by the user.
- Page 20 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The MicroRPM is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroRPM should assure that it is used in such an environment Emission Test Compliance...
- Page 21 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The MicroRPM is intended for use in the electromagnetic environment specified below. The customer or the user of the MicroRPM should assure that it is used in such an environment. Immunity...
- Page 22 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MicroRPM is used exceeds the applicable RF compliance level above, the MicroRPM should be observed to verify normal operation. If...
- Page 23 MicroRPM The MicroRPM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MicroRPM can help prevent electromagnetic interference by maintaining a minimum distance...
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Page 24: Symbols
Symbols Type B device In accordance with Directive 93/42/EEC Disposal in compliance with your local recycling facility Consult the instructions for use Date of Manufacture Manufacturer Serial Number Single Patient Use Federal U.S. law restricts this device to sale by or Rx only on the order of a physician (Rx only) -
Page 25: Specifications
Specifications Maximum Expiratory Pressure (MEP) Measurements Maximum Inspiratory Pressure (MIP) Sniff Nasal Inspiratory Pressure (SNIP) Maximum Rate of Pressure With Puma Development (MRPD) Maximum Rate of Relaxation (MRR) Operating Pressure +/- 300 cmH2O (+/- 5 PSID) Burst Pressure +/- 700 CmH2O (+/- 20 PSID) Accuracy +/- 3% Resolution... -
Page 26: Consumables / Supporting Products
Large nasal probes (10 per box) ASS1091 Nasal probe adapter 48-70 Protex Disinfectant Wipe (100/canister) To place an order for consumables/supporting products or for general enquiries please contact Micro Direct on: Tel: (207) 786-7808 Toll-Free: (800) 588-3381 (US and Canada only) Fax:...
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